Job Overview We are seeking a Laboratory Technician responsible for performing routine laboratory testing in support of medical device and pharmaceutical manufacturing operations. Under direct supervision and following approved procedures, this position performs environmental monitoring, basic analytical measurements (pH, TOC, conductivity, weight), and physical attribute testing of in-process and finished products. This role maintains laboratory housekeeping and operates in full compliance with current Good Manufacturing Practices (cGMP) and applicable standard operating procedures (SOPs). Duties Perform routine environmental monitoring (EM) of cleanrooms and controlled areas, including viable air sampling, surface sampling, non-viable particle counts, and personnel monitoring, per approved SOPs and schedules. Perform routine analytical measurements including pH, Total Organic Carbon (TOC), and conductivity on water systems, in-process samples, and finished products under direct supervision. Perform physical attribute testing (e.g., dimensions, appearance, color, fill volume/weight checks) on components, in-process materials, and finished products. Collect, label, log, and transport samples while maintaining proper sample integrity, traceability, and chain of custody. Record test data accurately, legibly, and contemporaneously in laboratory notebooks, logbooks, batch records, and/or electronic records systems in accordance with Good Documentation Practices (GDP). Perform daily verification, calibration checks, and routine maintenance of basic laboratory equipment (balances, pH meters, conductivity meters) and document results. Prepare basic reagents, buffers, standards, and media as directed, with appropriate labeling and expiration dating. Maintain laboratory housekeeping, including cleaning of benches, equipment, and work areas; proper disposal of waste; and stocking of laboratory supplies and consumables. Notify the supervisor immediately of any out-of-specification (OOS), out-of-trend (OOT), atypical results, or equipment malfunctions. Support laboratory inventory by monitoring supply levels and reporting reorder needs. Perform other related duties as assigned by laboratory management. Requirements Proven experience working within medical device or pharmaceutical manufacturing environments with a strong understanding of

ISO 13485, FDA

regulations, HACCP, CGMP, and

ISO 9001

standards. Proficiency in operating precision measurement instruments including calipers, micrometers, vision inspection systems, coordinate measuring machines (CMM), and other quality inspection tools. Familiarity with Calypso software for data collection and analysis is highly desirable. Strong analysis skills with the ability to interpret measurement data accurately and identify deviations or trends. Experience conducting quality audits and supporting quality assurance activities within manufacturing settings. Knowledge of quality management principles related to QA/QC processes, documentation control, and regulatory compliance. Excellent attention to detail combined with effective communication skills for documenting findings clearly. Ability to work independently or as part of a team in a fast-paced environment while maintaining high standards of accuracy. Join us in our mission to deliver safe, reliable medical devices and pharmaceutical products by ensuring the highest levels of quality! This role is ideal for professionals passionate about maintaining rigorous quality standards through precise measurement techniques and comprehensive compliance practices. Compliance and GMP Responsibilities Comply with all cGMP requirements (21 CFR Parts 210/211 and 820, and

ISO 13485

as applicable), SOPs, and safety policies. Follow Good Documentation Practices (ALCOA+ principles) in all record-keeping activities. Adhere to gowning, aseptic behavior, and material/personnel flow requirements in classified areas. Complete all assigned training prior to performing tasks independently and maintain training records in a current state. Report deviations, errors, and safety incidents promptly to the supervisor. Education and Experience High school diploma or GED with 2-4 years of relevant laboratory experience required. Associate or bachelor's degree in a science-related field (Biology, Chemistry, Microbiology, or similar) with 0-2 years of laboratory experience. Experience in a GMP-regulated pharmaceutical or medical device environment is preferred. Knowledge, Skills, and Abilities Basic understanding of laboratory practices, measurement techniques, and safety procedures. Ability to accurately follow written procedures and verbal instructions. Strong attention to detail and commitment to data accuracy. Basic math skills, including unit conversions and use of significant figures. Basic computer skills (Microsoft Word, Excel, Outlook); ability to learn MasterControl and other electronic systems. Effective verbal and written communication skills; ability to work cooperatively in a team environment. Dependability, punctuality, and willingness to learn. #

PKJOBS Pay:

$22.00 - $26.00 per hour

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Referral program Vision insurance

Work Location:

In person